Multiple MyelomaPROMMISNCT02911571
PRospective Multiple Myeloma Impact Study
A study testing MMprofiler SKY92 gene signature in people with Multiple Myeloma, run by SkylineDx at 9 sites in United States.
Trial summary
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- MMprofiler SKY92 gene signature
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 9 sitesUnited States
- Study dates
- 27 Feb 2018to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potentially multiple myeloma according to IMWG criteria
- Candidates for systemic treatment
Who cannot join
- ECOG Performance Status > 3
- Tumor sample that fails QA or QC criteria for MMprofiler
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Levine Cancer Institute
Charlotte, North Carolina, 28204
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Columbia University Medical Center
New York, New York, 10032
Weill Cornell Medicine
New York, New York, 10065
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Wake Forest Baptist Medical Center,
Winston-Salem, North Carolina, 27157
About this study
Official title: Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.
Read the detailed description
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in MM patients.
Eligible patients will have their tumor sample analyzed for the prognostic MMprofiler SKY92, several cytogenetic markers, gene expression markers, and gene expression clusters.
A total of 250 patients will be enrolled from up to 9 US centers. Patients will be followed 5 years after diagnosis.
- Conditions
- Multiple Myeloma
- Being tested
- MMprofiler SKY92 gene signature
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMprofiler SKY92 gene signatureDevice
MMprofiler is a gene expression assay system for detection of the presence (or absence) of the SKY92 "high-risk" gene signature to aid in the determination of the Multiple Myeloma patient's prognosis
| Study group | Role | What they receive |
|---|---|---|
| MMprofiler SKY92 | Experimental | Eligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature Receives: Device: MMprofiler SKY92 gene signature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in treatment intention
Change in treatment intention will be assessed with a physician questionnaire pre- and post MMprofiler assessment
Measured: Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler
Secondary outcomes (4)
3 year Progression Free Survival
Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
Measured: 3 years after diagnosis
3 year Overall Survival
Duration from start of the treatment to death (regardless of cause of death).
Measured: 3 years after diagnosis
5 year Progression Free Survival
Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
Measured: 5 years after diagnosis
5 year Overall Survival
Duration from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
Measured: 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start27 Feb 2018
- Primary completion18 Apr 2022
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SkylineDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medex15
- Responsible party
- Sponsor
- Investigators
- Saad Usmani, MD, Principal investigator, Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911571
- Sponsor's protocol ID
- PROMMIS
- Acronym
- PROMMIS
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2016
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study to Measure the Impact of MMprofiler on Treatment Intention in Active Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT02911571
- Acronym / sponsor ID
- PROMMIS / PROMMIS
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- SkylineDxIndustry (pharma, biotech, devices)
- Collaborators
- Medex15
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in Multiple Myeloma patients.
Detailed description
This will be a prospective, case-only, study to measure the impact of MMprofiler on treatment intention decisions in MM patients.
Eligible patients will have their tumor sample analyzed for the prognostic MMprofiler SKY92, several cytogenetic markers, gene expression markers, and gene expression clusters.
A total of 250 patients will be enrolled from up to 9 US centers. Patients will be followed 5 years after diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MMprofiler SKY92 | Experimental | Device: MMprofiler SKY92 gene signatureEligible patients will have their bone marrow biopsy sample analyzed for the prognostic MMprofiler SKY92 gene signature |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Potentially multiple myeloma according to IMWG criteria
- Candidates for systemic treatment
Key exclusion criteria (2 listed)
- ECOG Performance Status > 3
- Tumor sample that fails QA or QC criteria for MMprofiler
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMprofiler SKY92 gene signatureMMprofiler is a gene expression assay system for detection of the presence (or absence) of the SKY92 "high-risk" gene signature to aid in the determination of the Multiple Myeloma patient's prognosis | Device | MMprofiler SKY92 |
Primary outcome
Change in treatment intention
Time frame: Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler
Change in treatment intention will be assessed with a physician questionnaire pre- and post MMprofiler assessment
4 secondary outcomes
3 year Progression Free Survival
Time frame: 3 years after diagnosis
3 year Overall Survival
Time frame: 3 years after diagnosis
5 year Progression Free Survival
Time frame: 5 years after diagnosis
5 year Overall Survival
Time frame: 5 years after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
RecruitingObservational study
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
RecruitingPhase 1/2
Study of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in Multiple Myeloma
Multiple Myeloma
RecruitingObservational study
Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols
Multiple Myeloma, Lymphoma, Non-Hodgkin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saad Usmani, MD principal investigator
Charlotte Mecklenburg Hospital Authority, Carolinas HealthCare System
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMprofiler SKY92 gene signature in people with Multiple Myeloma, run by SkylineDx at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in treatment intention (time frame: Treatment intention is measured before MMprofiler SKY92 and within 4 weeks after MMprofiler). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.